Clinical Research Associate, Germany - L

Employer
CROMSOURCE
Location
Germany - Home-based
Salary
Competitive
Closing date
1 Oct 2020

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
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Description:
Job Title: Clinical Research Associate

Location: Germany

Schedule: Full time, Home-based

The role is open also for freelancers (FTE 0.4 - 0.5)

In this role you will be working in with our in-house team. You will be responsible for full site management from feasibility to close out of studies. We have a varied client base, ranging from small-mid sized Pharma and Medical Device companies.

Main Job Tasks and Responsibilities
  • Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigation sites
  • Performs training of site staff in all study procedures in order to ensure protocol/ICHGCP compliance
  • Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety
  • Adapts and translates Patient Information Leaflets and Informed Consent Forms
  • Cooperates with the site staff for ensuring a proper reporting from the site of the safety issues (adverse events and adverse reaction such as AEs/SAEs, SUSARs, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues
  • Escalates any issues to relevant project team members
  • May assist in contract negotiation with sites on study budget after appropriate and documented training
  • May support the submission process in the project (or region)


Education and Experience
  • You have a University Degree in scientific medical or paramedical discipline
  • Prior experience as a CRA
  • Excellent knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirement
  • Fluent in English
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook
  • Willingness to travel


If you have the experience needed for this position, please apply directly @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002308

If you would like to discuss the role before applying through the website please contact alessandra.bolognani@cromsource.com for more information

Why CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Keywords

CRA, Clinical Research Associate, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, submissions, Clinical Research ICH-GCP, Monitoring, Home based, Germany, Deutschland
Skills: Clinical Research Associate, CRO, ICH-GCP, Monitoring Location: Germany - Home-based Share:

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CROMSOURCE is an ISO-certified international provider of fully outsourced services to the pharmaceutical, biotechnology and medical device industries, specialised in clinical development and flexible resourcing solutions. CROMSOURCE was founded in 1997 and its successful growth has been built on stability, integrity, and high levels of customer satisfaction. We have grown steadily through offices across all regions of Europe and North America and delivering a comprehensive breadth of services.

Acting through PharmaceuticalMedical Device and Flexible Resourcing Solutions teams, and with a comprehensive portfolio of services, we offer a flexible approach to ensure CROMSOURCE optimally supports the unique needs of each client. This could mean providing regulatory consultancy to a small company at the early stages of a medical device development programme, through to provision of full services to a pharmaceutical company performing an international mega-trial to support registration of their product. Whatever the size and scope of the project, each receives the same level of attention to detail and commitment to delivery of a high quality service within budget and to timelines agreed.

We are experts providing experts and we live by our motto – Advise Agree Deliver. This means we leverage our experience and expertise at the early stages of discussions with our clients to freely advise them on the optimal project plan. We then reach agreement with each client on the scope of service, timelines and budget. CROMSOURCE then commit to deliver those services on time and within budget – according to our End-to-End Guarantee and this commitment to guaranteed delivery is unique in the clinical research environment.

Contact Us
  • 6-9 The Square
  • Stockley Park
  • Hayes
  • UB11 1FW
  • United Kingdom
  • +44 (0) 1786 468990
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